FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
TNI Clear-Guard 3 angled breathing filter (1545020)
K Number: K223258
·
Decision Jun 15, 2023
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
1
Review Days
237
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Basic Information
- Device Name
- TNI Clear-Guard 3 angled breathing filter (1545020)
- K Number
- K223258
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intersurgical , Ltd.
- Date Received
- October 21, 2022
- Decision Date
- June 15, 2023
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | FDA class 2 | Anesthesiology |
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